[Federal Register Volume 86, Number 195 (Wednesday, October 13, 2021)]
[Notices]
[Pages 56960-56963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22108]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-1106]
Alcohol-Based Hand Sanitizer Products; Withdrawal of Three
Temporary Guidance Documents Issued During the Public Health Emergency
of the Coronavirus Disease 2019
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; withdrawal.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the withdrawal of three guidance documents entitled
[[Page 56961]]
``Temporary Policy for Preparation of Certain Alcohol-Based Hand
Sanitizer Products During the Public Health Emergency (COVID-19),''
``Policy for Temporary Compounding of Certain Alcohol-Based Hand
Sanitizer Products During the Public Health Emergency,'' and
``Temporary Policy for Manufacture of Alcohol for Incorporation Into
Alcohol-Based Hand Sanitizer Products During the Public Health
Emergency (COVID-19),'' which were issued in March 2020 (and updated
March 27, 2020, April 15, 2020, June 1, 2020, August 7, 2020, and
February 10, 2021). FDA is withdrawing these three guidance documents
because current data indicate that consumers and healthcare personnel
are no longer experiencing difficulties accessing alcohol-based hand
sanitizer products, and these temporary policies are no longer needed
to help meet demand for alcohol-based hand sanitizer products or for
alcohol for use in alcohol-based hand sanitizer.
DATES: The withdrawal date for the three guidances is December 31,
2021. Firms manufacturing alcohol under the temporary policies for use
in alcohol-based hand sanitizers and firms preparing alcohol-based hand
sanitizers under the temporary policies must cease production of these
products by December 31, 2021. Firms must cease, by March 31, 2022,
distribution of any remaining hand sanitizer products that were
prepared under the temporary policies before or on December 31, 2021.
After March 31, 2022, FDA intends to cease its temporary policy of not
taking action with regard to distribution of hand sanitizers, or
alcohol for use in alcohol-based hand sanitizers, prepared consistent
with the circumstances described in the guidance documents.
FOR FURTHER INFORMATION CONTACT: Kimberly Thomas, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993, 301-796-3600.
SUPPLEMENTARY INFORMATION:
I. Background
As part of FDA's commitment to providing timely guidance to support
continuity and response efforts to the Coronavirus Disease 2019 (COVID-
19) \1\ pandemic, in March 2020, the Agency published three guidance
documents to provide regulatory flexibility to certain firms to help
meet the demand for alcohol-based hand sanitizer during the COVID-19
public health emergency (PHE).\2\ The guidance documents communicate
the Agency's temporary policies on the manufacture of alcohol for use
in alcohol-based hand sanitizers, or alcohol-based hand sanitizers for
consumer use and for use as healthcare personnel hand rubs \3\ for the
duration of the PHE declared by the Secretary of Health and Human
Services on January 31, 2020, and subsequently renewed. The following
is a brief description of each guidance:
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\1\ The virus has been named ``SARS-CoV-2'' and the disease it
causes has been named ``Coronavirus Disease 2019'' (COVID-19).
\2\ For example, as explained in the guidance entitled
``Temporary Policy for Preparation of Certain Alcohol-Based Hand
Sanitizer Products During the Public Health Emergency (COVID-19),''
provided that circumstances described in the guidance are present,
FDA does not intend to take action against firms, for the duration
of the public health emergency, for violations of sections 319(a)(2)
of the Public Health Service Act (42 U.S.C. 247d(a)(2)) or sections
501(a)(2)(B), 502(f)(1), 505, or 582 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 351(a)(2)(B), 352(f)(1), 355, and
360eee-1), which include certain aspects of current good
manufacturing practice, certain labeling requirements, new drug
application requirements, and pharmaceutical distribution supply
chain requirements.
\3\ FDA uses the term ``hand sanitizer'' throughout this Notice
of Withdrawal, and the referenced guidance documents, to refer to
OTC topical antiseptic rubs for use by consumers, as well as those
for use by healthcare personnel in hospital and healthcare settings.
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The first guidance,\4\ ``Temporary Policy for Preparation
of Certain Alcohol-Based Hand Sanitizer Products During the Public
Health Emergency (COVID-19),'' communicates FDA's policy for the
temporary preparation of certain alcohol-based hand sanitizer products
by firms that register their establishment with FDA as a
nonprescription over-the-counter (OTC) drug manufacturer, re-packager,
or re-labeler, under the circumstances described in the guidance.
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\4\ Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-temporary-policy-preparation-certain-alcohol-based-hand-sanitizer-products-during.
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The second guidance,\5\ ``Policy for Temporary Compounding
of Certain Alcohol-Based Hand Sanitizer Products During the Public
Health Emergency,'' communicates FDA's policy for the temporary
compounding of certain alcohol-based hand sanitizer products by
pharmacists in State- or territory-licensed pharmacies or Federal
facilities and registered outsourcing facilities, under the
circumstances described in the guidance.
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\5\ Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-temporary-compounding-certain-alcohol-based-hand-sanitizer-products-during-public-health.
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The third guidance,\6\ ``Temporary Policy for Manufacture
of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products
During the Public Health Emergency (COVID-19),'' communicates FDA's
policy for the temporary manufacture of alcohol (i.e., ethanol or ethyl
alcohol) by firms for use as the active pharmaceutical ingredient in
alcohol-based hand sanitizers under the circumstances described in the
guidance.
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\6\ Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policy-manufacture-alcohol-incorporation-alcohol-based-hand-sanitizer-products-during.
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We appreciate industry's willingness to help supply hand sanitizer
to the market in response to the COVID-19 PHE.
As explained in these guidance documents, FDA has continually
assessed the needs and circumstances related to these temporary
policies, and as relevant needs and circumstances evolved, FDA made
updates and modifications to these temporary policies. The guidance
documents also state that this assessment includes withdrawing these
temporary policies as appropriate.
Based on our review of currently available data, we have determined
that the needs and circumstances related to these temporary policies
have evolved such that the temporary policies are no longer needed and
the three guidance documents should be withdrawn.\7\ As explained in
this document, this determination is based on current data that show
that demand for alcohol-based hand sanitizer has decreased and the
supply of hand sanitizer from traditional manufacturers (i.e., firms
other than those that entered into the OTC drug industry for the first
time in order to supply hand sanitizers during the COVID-19 PHE) has
increased. Most consumers and healthcare personnel are no longer
experiencing difficulties accessing alcohol-based hand sanitizer
products.
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\7\ We note that withdrawal of these guidance documents will not
cause an assessment of fees on manufacturers of OTC hand sanitizers
under the Over-the-Counter Monograph Drug User Fee Program (OMUFA).
OMUFA fees are distinct from these guidance documents and are
addressed in FDA's Federal Register notice of March 26, 2021 (86 FR
16223), entitled ``Fee Rates Under the Over-the-Counter Monograph
Drug User Fee Program for Fiscal Year 2021.'' As this Federal
Register notice explains, ``FDA will not assess OMUFA facility fees
upon those firms that first registered with FDA on or after the
January 27, 2020 declaration of the COVID-19 Public Health Emergency
(PHE), solely for purposes of manufacturing hand sanitizer products
during the PHE'' (86 FR 16223 at 16225). Additional information is
available in this FDA Federal Register notice and the Health and
Human Services Federal Register notice of January 12, 2021 (86 FR
2420).
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During the course of the COVID-19 PHE, FDA has conducted several
surveys of hospital systems to monitor
[[Page 56962]]
the supply and sources of alcohol-based hand sanitizer products. Based
on the results of these surveys, current data show that the hand
sanitizer supply disruption in hospitals has decreased significantly
and that hand sanitizer from traditional manufacturers now comprise the
majority of these hospital systems' supply. Specifically, all the
hospital systems that responded to FDA's July 2021 survey on hand
sanitizer supply stated that they are not experiencing a current
disruption in their supply of hand sanitizer, and only 9 percent of
these hospital systems anticipated a future disruption in supply. In
addition, 94 percent of the hospital systems responding to the July
2021 survey reported that the majority of their current hand sanitizer
product is produced by traditional manufacturers. Recent reports also
indicate that there is now a surplus of hand sanitizer products on
retail shelves.\8\ Moreover, certain traditional hand sanitizer
manufacturers indicate that they are able to meet demand and fully
supply the marketplace with hand sanitizer products.\9\ A large
manufacturer of hand sanitizer products has expanded production
capacity and is producing and shipping 300 percent more hand sanitizer
product than in 2019.\10\
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\8\ See, e.g., the newspaper articles at https://www.wsj.com/articles/america-is-awash-in-hand-sanitizer-11621522829; https://www.washingtonpost.com/local/last-year-hand-sanitizer-was-a-precious-commodity-now-theyre-giving-it-away/2021/06/24/351f1278-d504-11eb-9f29-e9e6c9e843c6_story.html; https://www.usatoday.com/story/money/2021/04/08/hand-sanitizer-deals-donations-surplus-panic-buying-pandemic/7120815002/ (Refs. 1, 2, and 3).
\9\ See April 28, 2021, letter from the American Cleaning
Institute/Consumer Healthcare Products Association to FDA, available
at https://www.regulations.gov/comment/FDA-2020-D-1106-0164 (Ref. 4)
(stating that their members ``have the capacity to fully supply the
marketplace'' and have ``increased production of cGMP-compliant
products to meet the demand for both consumer and healthcare
markets,'' at 3).
\10\ See https://www.gojo.com/en/Newsroom/Press-Releases/2021/PURELL-Brand-Strongly-Positioned-to-Support-Safe-Reopening-of-Schools (Ref. 5).
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FDA published its temporary policies for alcohol-based hand
sanitizers in response to the increase in demand for alcohol-based hand
sanitizer products during the COVID-19 PHE and with the understanding
that some consumers and healthcare personnel were experiencing
difficulties accessing alcohol-based hand sanitizer products. Although
the PHE is still ongoing \11\ and there currently is an increase in
COVID-19 cases, the data indicate that: (1) Supply from traditional
manufacturers has increased; (2) the demand for alcohol-based hand
sanitizer that existed earlier in the pandemic has significantly
decreased; and (3) most consumers and healthcare personnel are no
longer having difficulty accessing alcohol-based hand sanitizer
products. Additionally, since declaration of the COVID-19 PHE,\12\ some
hand sanitizer products made by firms that entered the market during
the COVID-19 PHE have been recalled, placed on import alert, and/or
been the subject of compliance actions due to quality and other issues.
Accordingly, the needs and circumstances related to these temporary
policies have evolved such that the temporary policies are no longer
warranted and the guidance documents should be withdrawn.
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\11\ Secretary of Health and Human Services,'' Determination
that a Public Health Emergency Exists Nationwide as the Result of
the 2019 Novel Coronavirus'' (originally issued January 31, 2020,
and subsequently renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx (Ref. 6).
\12\ The HHS Declaration of a Public Health Emergency is
available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.
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We note that the recently enacted Coronavirus Aid, Relief, and
Economic Security Act (Pub. L. 116-136) added section 505G to the FD&C
Act (21 U.S.C. 355g). Under section 505G(a)(3) of the FD&C Act, drugs
that were classified as category III \13\ in a tentative final
monograph (TFM) that is the most recently applicable proposal or
determination for such drugs issued under 21 CFR part 330--and that
were not classified in such a TFM as category II for safety or
effectiveness--are not required to have an approved application under
section 505 to be marketed, as long as they are in conformity with the
relevant conditions of use outlined in the applicable TFM and comply
with all other applicable requirements. This includes topical
antiseptic products marketed in conformity with the 1994 TFM for OTC
topical antiseptics (59 FR 31402, June 17, 1994) as further amended by
the 2016 Consumer Antiseptic Rub proposed rule (81 FR 42912, June 30,
2016) and the 2015 Health Care Antiseptics proposed rule (80 FR 25166,
May 1, 2015), as long as they also comply with other applicable
requirements.
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\13\ Under the OTC Drug Review, FDA classified drugs as category
III where FDA determined that the available data are insufficient to
classify the drug as generally recognized as safe and effective, and
further testing is required (see 21 CFR 330.10(a)(5)(iii) and
(a)(6)(iii)).
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Accordingly, although the temporary policies are being withdrawn as
described above, firms may continue to manufacture alcohol-based hand
sanitizer products without an approved application, provided they
comply with the applicable TFM and other applicable requirements,
including current good manufacturing practice (CGMP) requirements under
section 501(a)(2)(B) of the FD&C Act. Under CGMP, among other things,
drug product manufacturers are required \14\ to test their drug
products prior to release to assure that the drug products meet the
requirements for safety and have the identity and strength, and meet
the quality and purity characteristics, that the drug products purport
to possess. We remind distributors, re-packagers, and importers that
they are also responsible for the safety and quality of the drugs they
introduce into interstate commerce.
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\14\ See 21 CFR 211.165 Testing and release for distribution.
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Firms preparing alcohol-based hand sanitizer products under FDA's
temporary policies (other than compounding pharmacies) had to register
their facility and list these products in the FDA Drug Registration and
Listing System (DRLS, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/drug-registration-and-listing-system-drls-and-edrls).\15\ We remind firms that registered and submitted drug product
listing(s) for hand sanitizer(s) only but no longer manufacture such
product, or plan to cease manufacturing such product, to deregister and
delist their hand sanitizer product listing(s) by following the
instructions on the Electronic Drug Registration and Listing
Instructions page (https://www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/electronic-drug-registration-and-listing-instructions).
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\15\ Every person required to register with FDA must, at the
time of initial registration, list all drugs manufactured, prepared,
propagated, compounded, or processed for commercial distribution.
See section 510(j)(1) of the FD&C Act (21 U.S.C. 360(j)(1)); see
also 21 CFR 207.17 and 207.41. Firms that are required to register
their foreign establishment with FDA must list all known importers
in the United States in their registration in accordance with
section 510(i)(1)(A) of the FD&C Act. See also 21 CFR 207.25(h)(2).
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To deregister an establishment using CDER Direct:
Log into your account and open the previously accepted
version of the registration submission.
Click on CREATE NEW VERSION. This will create a copy of
the file, keeping the same SetID, but generate a new RootID, Version
Number, and Effective Date.
For Document type, Select ESTABLISHMENT DE-REGISTRATION
from the drop-down list.
Click SUBMIT SPL.
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To deregister an establishment from other software applications:
Create an establishment deregistration SPL document.
Fill in the SetID with the SetID from your previously
accepted version.
Enter the appropriate effective date and version number
(generally, one number higher than the previous submission).
Submit.
To delist a product using CDER Direct:
Log into your account and open the previously accepted
version of drug listing submission.
Click on CREATE NEW VERSION. This will create a copy of
the file, keeping the same SetID, but generate a new RootID, Version
Number, and Effective date.
Click on the product to edit the Product Data Elements.
Change the Marketing Status from ``ACTIVE'' to ``COMPLETED'' and enter
a Marketing End Date no later than March 31, 2022.
Save changes and click SUBMIT SPL.
To delist a product from other software applications:
Open the previously accepted version of drug listing
submission.
Create a new version with the same SetID from your
previous submission, but generate a new RootID.
Enter the appropriate effective date and version number
(generally, one number higher than the previous submission).
Edit the product data elements. Change the Marketing
Status from ``ACTIVE'' to ``COMPLETED'' and enter a Marketing End Date
no later than March 31, 2022.
Save and Submit.
To request additional assistance with deregistration and delisting,
please contact [email protected].
II. Withdrawal Date
The withdrawal date for the three guidance documents discussed in
this document is December 31, 2021. Accordingly, firms manufacturing
alcohol under the temporary policies for use in alcohol-based hand
sanitizers and firms and compounders preparing alcohol-based hand
sanitizers under the temporary policies must cease production of these
products by December 31, 2021. In addition, firms must by March 31,
2022, cease distribution of any remaining hand sanitizer products that
were prepared under the temporary policies before or on December 31,
2021. After March 31, 2022, FDA intends to cease its temporary policy
of not taking action with regard to distribution of hand sanitizers or
alcohol for use in alcohol-based hand sanitizers prepared consistent
with the circumstances described in the withdrawn guidance documents.
The COVID-19 pandemic is a constantly evolving situation. FDA continues
to assess these circumstances and should the current data change to
indicate that hand sanitizer demand has again outstripped supply prior
to December 31, 2021, FDA may alter these dates. However, firms should
assume these dates will not change and prepare accordingly for
cessation of manufacture and distribution of these products.
III. References
The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500, and are available for viewing by interested persons between 9
a.m. and 4 p.m., Monday through Friday; they are also available
electronically at http://www.regulations.gov. References in the Notice
without asterisks are not available electronically at https://www.regulations.gov because they have copyright restrictions, but they
are on display at the Dockets Management Staff and available for
viewing at the location and times noted above. Some may be available at
the website address, if any, listed with the reference or such website
may provide further information on obtaining copies. FDA has verified
the website addresses, as of the date this document publishes in the
Federal Register, but websites are subject to change over time.
1. Kang, J., ``Retailers Couldn't Stock Hand Sanitizer Fast Enough.
Now They Can't Give It Away,'' The Wall Street Journal, May 20,
2021, (available at https://www.wsj.com/articles/america-is-awash-in-hand-sanitizer-11621522829), accessed August 30, 2021.
2. Dvorak, P., ``Last Year, Hand Sanitizer Was a Precious Commodity.
Now They're Giving It Away,'' The Washington Post, June 24, 2021
(available at https://www.washingtonpost.com/local/last-year-hand-sanitizer-was-a-precious-commodity-now-theyre-giving-it-away/2021/06/24/351f1278-d504-11eb-9f29-e9e6c9e843c6_story.html), accessed
August 30, 2021.
3. Bomey, N., ``Panic Buying? Not Anymore. Suddenly There's a
Surplus of Hand Sanitizer,'' USA Today, April 8, 2021 (available at
https://www.usatoday.com/story/money/2021/04/08/hand-sanitizer-deals-donations-surplus-panic-buying-pandemic/7120815002/), accessed
August 30, 2021.
4. *Letter from James Kim and Barbara Kochanowski, ACI/CHPA, to
Theresa Michele, FDA, April 28, 2021 (available at https://www.regulations.gov/comment/FDA-2020-D-1106-0164), accessed August
30, 2021.
5. Gojo, ``PURELL Brand Strongly Positioned to Support Safe
Reopening of Schools,'' February 22, 2021 (available at https://www.gojo.com/en/Newsroom/Press-Releases/2021/PURELL-Brand-Strongly-Positioned-to-Support-Safe-Reopening-of-Schools), accessed August
30, 2021.
6. *Secretary of the Department of Health and Human Services,
``Determination that a Public Health Emergency Exists Nationwide as
the Result of the 2019 Novel Coronavirus,'' originally issued
January 31, 2020, and subsequently renewed (available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx),
accessed August 30, 2021.
Dated: October 5, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22108 Filed 10-12-21; 8:45 am]
BILLING CODE 4164-01-P